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Procedure Name

Import License procedure for medicines and medical devices, A/407

Description

Category	LICENSE
Responsible Agency	Name: MINISTRY OF HEALTH Address: Mongolia, Ulaanbaatar 14210 Sukhbaatar District 14210 Olympic Street - 2 Government Building VIII, E-mail: info@moh.gov.mn Web: https://www.mohs.mn/home Phone: (976) 51-263695 Fax: 11-320916
The legal base of the Procedure	On Approval of Procedure/Issuing import and export licenses for medicines and medical devices/, 2017
Fee	N/A
Processing time	5 working days Amendments to the license shall be reviewed and resolved within 3 working days.

Required Documents

No.	Type of information	Note
1	A trade agreement concluded by an importer of drugs and medical devices with a foreign pharmaceutical company or its official authorized distributor	Documents necessary for the application
2	Invoice for goods imported in accordance with the contract
3	A certificate confirming that the manufacturer and the product meet the requirements of international standards (ISO) for the import of medical devices
4	A proposal issued by the Public Health Department of the Ministry of Health for the import of a vaccine and a Lot Release certificate issued by the competent authority of the country exporting the vaccine

Process Steps

Step1	Imported drugs shall be registered in the Mongolian Drug Registry
Step2	The applicant shall obtain the access code to the electronic system from the Health Development Center
Step3	The application for a license shall be submitted in electronic form by entering the Internet-based electronic registration system for health sector licenses and import permits (www.moh.mn/Licemed/)
Step4	Documents submitted by the applicant shall be reviewed by the Center for Health Development
Step5	The applicant shall receive information on the process of processing the application for a license in electronic form
Step6	If the application is approved by the Director of the Drugs Department of the Ministry of Health, the Applicant receives the license to import medicines and medical devices

NOTE;

1. The Licensor shall have the right to inspect, verify, and issue an opinion on the applicant's documents by the relevant authority, if necessary. In this case, the period shall be extended

until the conclusion of the relevant authority and the applicant shall be responsible for the costs incurred in this connection.

2. The license shall be issued for a period of up to six months.

3. It is prohibited to transfer, sell, gift, or pledge the license

4. If a request is made stating the reasons for making an amendment during the term of the license, the amendment may be made based on the relevant documents

5. If it is necessary to change the type and quantity of drugs and medical devices specified in the license, a new application shall be submitted to obtain a license

6. Log in to the electronic system at the following web address and submit a license application and import report. http://www.moh.mn/licemed/

Category

Import

The following form/s are used in this procedure

Title	Description	Created Date	Updated Date	Issued By
Import/Export License for medicines and medical devices, 2017 Annex 2 to Order A / 407	This License form applies to traders wishing to import/export of medicines and medical devices. License relates the Import License procedure for medicines and medical devices	30-07-2020	08-10-2020	Ministry of Health

This procedure applies to the following measures

Name	Measure Type	Agency	Description	Comments	Legal Document	Validity To	Measure Class
License requirement for importing medicines and medical devices	Licensing Requirement	Ministry of Health	As per the Order on import and export of medicines and medical devices, this measure applies to traders who want to import medicines and medical devices any other country to Mongolia.	The application for a license shall clearly indicate the type, dosage, packaging, name of the manufacturer, quantity and border crossing of the drugs and medical devices to be imported in the shipment	On Approval of Procedure/Issuing import and export licenses for medicines and medical devices/, 2017	31-12-9999	Good